SEATTLE, Sept. 1, 2021 /PRNewswire/ -- Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, today announced the start of a Phase 1 trial of LMN-Cdiff01, an orally delivered investigational biologic for treatment and prevention of recurrent C. difficile infection (CDI). The first trial participant was dosed at Coral Sea Clinical Research Institute (CSCRI) in Mackay, Queensland, Australia.
The open-label, exploratory trial at CSRI is evaluating the delivery of LMN-Cdiff01 (previously known as LMN-201) via enteric capsules in the gut in healthy volunteers with mature ileostomies. The capsules are designed to release the proteins at or before the terminal ileum, the earliest point in the gastrointestinal (GI) tract where CDI become established in most patients. This study will give the researchers information about if these capsules release the LMN-Cdiff01 therapeutic proteins at the end of the small intestine as intended. Preliminary data from the trial are expected by December 2021. Lumen Bioscience is currently planning a Phase 2 trial to study the safety, tolerability, and efficacy of LMN-Cdiff01 in preventing CDI recurrence.
"This is an important study given the progression of some intestinal diseases despite the best therapies currently available," said Dr. James Daveson, a gastroenterologist who is a lead investigator for the study at CSCRI. "Lumen's technology may offer a new treatment approach, and we are pleased to be involved in this initial research."
"We are excited to harness Lumen's unique biologics platform to take on recurrent C. difficile infection, an urgent health threat associated with significant morbidity and mortality worldwide," said Brian Finrow, Lumen's co-founder and CEO. "Our technology is the first to allow for the cost-effective manufacturing of therapeutic proteins at a global scale, and we're pleased to have this opportunity to study a potential new way to prevent recurrence of this terrible disease."
LMN-Cdiff01 is a cocktail of two class of therapeutic protein expressed and delivered within whole spirulina biomass, a type of blue-green algae widely consumed as a nutritional supplement. The first class is comprised of three antibody-like proteins that bind and neutralize the bacterial toxin that is the main cause of the diarrhea and other severe symptoms of CDI. The second is a single enzyme protein that destroys the cell wall of the C. difficile bacterium itself without perturbing the patient's healthy GI microbiome. Rather than treating CDI, which today can be easily cleared with common antibiotics, LMN-Cdiff01 is intended to be delivered orally alongside standard-of-care antibiotics to prevent CDI recurrence, a common side effect of antibiotic treatment.
Lumen Bioscience discovers, develops, and manufactures biologic drug candidates for several prevalent, worldwide diseases—many of which currently lack any effective treatments. The company's unique drug development and manufacturing platform offers the potential to transform the biologics industry through increased speed, mass-market scale, and exponentially lower costs than current approaches. Lumen's clinical pipeline includes investigational biologic drugs for C. difficile infection, Covid-19, cardiometabolic disease, inflammatory bowel disease, norovirus, and traveler's diarrhea. For more information, visit: www.lumen.bio.